An interventional study of Data integration around responsive parenting and Standard Care (in control arm) in Weight Gain Trajectory, BMI and Responsive Parenting, sponsored by Penn State University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Penn State University · Not applicable, Interventional, and Prevention
This study looks at whether using secure digital systems to share information between pediatric health care providers (during regular well-child visits) and social care providers (during regular visits with WIC nutritionists) can help mothers receive consistent guidance on responsive parenting to support healthy child growth and development. Responsive parenting means learning how to respond to a baby's needs in ways that support healthy eating, sleep, activity, and emotion regulation habits. The main questions this study aims to answer are:
The investigators will compare the group that receives secure digital systems for sharing information on responsive parenting to a group that receives standard care (does not receive this) to see if secure digital systems for sharing information on responsive parenting work to support healthy child growth and development. The goal is to see if this approach can improve early health behaviors and reduce health disparities for families in rural, low-income communities.
The first two years of a child's life lay the foundation for developing healthy eating, sleep, activity, and emotion regulation habits. These habits can help lower the risk of obesity later in childhood. However, young children in low-income rural communities are more likely to experience poverty and have limited access to nutritious and affordable foods, contributing to a higher risk of obesity and cardiometabolic diseases. To reduce health disparities among young children living in rural low-income communities, there is a critical need for effective and scalable evidence-based interventions to support parents of young children starting early in life. Leveraging existing settings such as health care (standard well-child visits) and social care (Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) visits) for evidence-based intervention delivery is an effective way to reach the parents of young children living in low-income contexts, who have multiple visits with providers in these settings across the first 24 months of life. A series of reports from professional organizations have called for solution-oriented approaches, moving away from siloed health care (primary care providers (PCPs)) and social care (WIC nutritionists) towards integrated care between these settings using health information technologies (secure digital systems to share information) to enhance obesity prevention efforts and reduce health disparities. The goal of this research is to leverage existing care settings and use health information technologies to digitally integrate care and deliver an evidence-based, responsive parenting intervention to mother-infant dyads living in rural, low-income communities that experience health disparities. This research will include a two-arm randomized controlled trial to test the effectiveness of an integrated, patient-centered responsive parenting intervention on rapid infant weight gain and child BMI z-score at age 24 months (Aim 1), the effectiveness of the intervention on responsive parenting practices and child diet quality (Aim 2), an evaluation of whether the intervention is more or less effective in certain groups (Aim 3), and an evaluation of factors influencing effective implementation across health care, social care, and home settings (Aim 4). The investigators hypothesize that compared to standard care (siloed PCP and WIC nutritionist care), children in the integrated PCP-WIC nutritionist care will gain weight less rapidly from birth to 6 months and have a lower BMI z-score at age 24 months. Integrating care between trusted providers creates an opportunity to increase the time spent discussing child health in these often time-constrained settings, deliver consistent, integrated care on responsive parenting, and inform scalable efforts to promote healthy child growth from the start and reduce health disparities among children living in rural, low-income communities.
19 studies on the registry are indexed under Body-Weight Trajectory; 6 are open to participants now.
This study's planned enrollment of 380 is above the median of 119 across 15 interventional studies indexed under Body-Weight Trajectory.
Browse Body-Weight Trajectory studies →Penn State University is the lead sponsor of 270 studies on the registry; 53 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.
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Exclusion Criteria:
Integrated care between PCPs and WIC nutritionists using health information technologies to promote responsive parenting and healthy growth
Behavioral: Data integration around responsive parenting
Standard siloed care from PCPs and WIC nutritionists without using health information technologies to promote responsive parenting and healthy growth
Behavioral: Standard Care (in control arm)
The integrated PCP-WIC nutritionist care intervention group will receive 1) behavioral risk screening using a patient-reported outcome measure that is completed in the child's electronic health record; 2) an evidence-based responsive parenting curriculum ; 3) electronic integration and coordination between care settings to document and inform patient-centered messaging; and 4) telehealth coaching sessions and online educational modules to reinforce responsive parenting messaging at home.
Standard siloed care from PCPs and WIC nutritionists
Infant Weight Gain
Change in weight-for-age z-score (WAZ) from birth to 6 months, with positive conditional weight gain scores indicating rapid or faster than average infant weight gain and negative scores indicating slower than average infant weight gain.
Time frame: From birth to age 6 months
Child Body Mass Index
Body mass index z-scores at child age 24 months, calculated using WHO Child Growth Standards.
Time frame: At child age 24 months (end of the study)
Parent Feeding Practices
Differences in parent feeding practice scores between intervention and control conditions will be measured using the 12-item Baby's Basic Needs Questionnaire, which assesses context-based (e.g., before bed) and emotion-based (e.g., food to soothe) feeding during infancy. Items are scored on a 5-point scale with responses from Never (1) to Always (5). Items are averaged to create a score for each subscale, and all items are averaged to create a total score, with higher scores indicating greater use of context-based, emotion-based, and total food to soothe.
Time frame: From child age 2 to 6 months
Parent Feeding Practices
Differences in parent feeding practice scores between intervention and control conditions will be measured using the Structure and Control in Parent Feeding questionnaire, which assesses responsive, structure-based feeding practices (i.e., limit-setting, consistent routines) and non-responsive, control-based feeding practices (i.e., restriction, pressure to eat) during toddlerhood. Items are scored on a 5-point Likert scale (0 = never to 4 = always), with higher scores indicating higher frequency of engagement in a specific feeding behavior.
Time frame: From child age 9 to 24 months (end of study)
Parent Feeding Practices
Differences in parent feeding practice scores between intervention and control conditions will be assessed using the Feeding to Manage Child Behavior questionnaire, a 9-item measure that assesses parents' use of food to soothe and food as reward. Items are scored on a 5-point Likert scale (0 = never- 4 = always), with higher scores indicating higher frequency of engagement in food to soothe or as a reward.
Time frame: From child age 9 to 24 months (end of study)
Child Diet Quality
Differences in child diet quality scores between the intervention and control conditions will be measured using the Mediterranean Eating Pattern for Americans-Child version. This is a 6-item parent-report measure of a child's diet quality, tailored to the child's developmental age, that captures recommended foods (e.g., fruits, vegetables, human milk) and non-recommended foods (e.g., sweets, SSBs, fast foods). The total score could range from 0 to 6. Scores will be converted to points on a 100-point scale using the 6-item measure's quantiles. For example, scores of 0 (0 points), 3 (55 points), and 6 (100 points), with higher scores meaning better diet quality.
Time frame: From child age 2 to 24 months (end of study)
Moderators of Intervention Effectiveness on Child BMI Z-scores
Moderators of intervention effectiveness on child BMI z-scores will include child characteristics (e.g., sex, temperament, appetitive traits), maternal psychosocial factors (e.g., perceived stress, social support), and social determinants of health (e.g., income, food and nutrition security, access to reliable transportation).
Time frame: At child age 24 months (end of study)
Start is estimated for Nov 2026; primary completion for Jun 2030, 43 months later.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: start Aug 2026 → Nov 2026, primary completion Dec 2029 → Jun 2030 and completion Dec 2029 → Jun 2030.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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